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The ongoing clinical trial in metastatic pancreatic cancer patients (CEND1-001, Clinical trial
reference NCT03517176) has been accruing patients rapidly – the first Phase 2a -type expansion
cohort for early efficacy is now open. The study is expected to be fully enrolled with at least 30
patients in the second quarter of 2019. The early results are reportedly encouraging, with high
response rates as well as favorable safety profile, with no dose-limiting toxicities. "The progress
with the pancreatic cancer trial has exceeded our expectations” said Harri Jarvelainen, Chief
Operating Officer of DrugCendR Inc. “Our near term goal is to validate the CEND-1 platform
technology in multiple indications so clinicians can treat patients with cancers with high unmet
medical need more effectively."
Receiving the FDA orphan drug designation was also announced today. It is a significant
development milestone as it can facilitate the future development through several benefits
such as tax credits for qualified clinical trials costs, exemptions from certain FDA application
fees, and seven years of market exclusivity upon regulatory product approval. The FDA grants
orphan drug designation to drugs and biologics that are intended for the treatment of rare
diseases that affect fewer than 200,000 people in the U.S.
Lastly, the company announced that it has appointed Heidi Henson, an industry veteran, to its
Board of Directors. “I am pleased to welcome Heidi Henson to our board, where her extensive
expertise in financial management and strategy will be a major asset to DrugCendR as we
continue to advance the company programs.” said Erkki Ruoslahti, M.D., Ph.D., Founder,
President, Chief Executive Officer and Chairman of DrugCendR. Mrs Henson, an independent
board member, is the Chief Financial Officer of Respivant Biosciences. Her previous experience
includes serving as the Chief Financial Officer of Kura Oncology and Wellspring Bioscience.
About CEND-1
About DrugCendR
DrugCendR Inc. is a privately held biopharmaceutical company founded in 2015. The company
was spun out of the laboratory of Dr. Erkki Ruoslahti of Sanford Burnham Prebys Medical
Discovery Institute. The initial focus of company’s technology is pancreatic cancer because, in
addition to its poor prognosis, it is characterized by a dense extracellular matrix stroma, which
acts as a physical barrier to drug entry. Since the active transport process initiated by CEND-1
overcomes this obstacle, and the target receptors for are highly expressed in advanced
pancreatic cancer, CEND-1 appears particularly well suited to target PDAC. The company is
planning for additional clinical trials in other cancer indications for its lead program and has
already started a follow-up CEND-2 program, which works through a well-validated immune-
oncology pathway.